Table 3. Summary of treatment-emergent adverse events (safety population).
|
No. of patients (%)
|
||
|---|---|---|
| ASA404-CP (n=37) | CP (n=36) | |
| ⩾1 adverse event | 34 (91.9) | 36 (100.0) |
| Related to ASA404 | 27 (73.0) | — |
| Related to standard therapy | 28 (75.7) | 31 (86.1) |
| Grade 1a/mildb | 3 (8.1) | 4 (11.1) |
| Grade 2a/moderateb | 6 (16.2) | 8 (22.2) |
| Grade 3a/severeb | 17 (45.9) | 22 (61.1) |
| Grade 4a,b | 5 (13.5) | 0 |
| Grade 5a,b | 3 (8.1) | 2 (5.6) |
| ⩾1 serious adverse event | 16 (43.2) | 17 (47.2) |
| Related to ASA404 | 1 (2.7) | 0 |
| Related to standard therapy | 5 (13.5) | 6 (16.7) |
| Adverse event leading to death | 2 (5.4) | 2 (5.6) |
| Adverse event leading to withdrawal | 5 (13.5) | 9 (25.0) |
ASA404-CP=ASA404 combined with carboplatin and paclitaxel; CP=carboplatin and paclitaxel.
a
National Cancer Institute Common Terminology Criteria for Adverse Events grading.
b
Worst severity grade.